Manual of Standard Operating Procedures and Policies
Regulatory Information Systems |
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Administrative Handling of Change Requests for Regulatory Review Automated Support Systems |
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SOPP 8008.1 |
Version #1 |
April 16, 2001 |
Appendix - CBER Regulatory Information Systems Change Control Board Charter
Purpose
This charter describes the duties and responsibilities for the regulatory information systems Change Control Board (CCB), the organization of its membership, and its operating procedures.
Background
CBER's Strategic Plan for 2004 has as one of its goals "Interactive Information Systems which are Integral to all CBER Activities." Two strategies to accomplish this goal are to "fully integrate information systems to support a seamless regulatory process" and "support the development and use of interactive databases." Substantial efforts have been made by the Center in adding, improving or replacing existing information systems. Oversight of these efforts has been the responsibility of the Information Management Coordinating Committee (IMCC).
A key component of information system support, during and after development of the databases, is a formal, organized process for change control by the users. Responsibility in this area has varied, particularly for systems in development. Although the BIMS/BRMS Users Subcommittee (BUS) has played a significant role in handling change requests for BIMS and BRMS for a number of years, the expansion of regulatory information systems requires a more formal and visible group to oversee the change control process. The CCB, a sub-committee of the Review Management Coordinating Committee (RMCC), will replace the BUS with expanded responsibilities and authority.
Responsibilities
The CCB is intended to be a forum, available to all CBER Offices, to discuss and make decisions or recommendations on user change requests (CRs) for the Center's regulatory review automated support systems. The primary responsibility of the CCB is to handle CRs. System problem reports will be managed by the Office of Information Technology Management. The CCB will help assure that the system support needs of each office are met to the extent possible given available programming resources and priorities, and that overall system and data integrity are maintained. The CCB will provide recommendations, Standard Operating Procedures and other work products to the RMCC.
Specifically, the CCB will be responsible for:
- Receiving or initiating all system CRs
- Reviewing and discussing the CRs
- Determining, in a timely fashion, which CRs should be acted on (with or without modification), which should be rejected, which should be deferred
- Prioritizing and establishing timeframes for CRs to be acted on
- Presenting CRs to the RMCC for approval, as appropriate
- Tracking and documenting action on all CRs
- Providing regular status updates on the CRs and the CCBs actions to the RMCC
Organization
The Board will be organized as follows:
- Chair (RIMS Director)
- Representatives and alternates from each office in CBER. Users for each system will be represented as either a representative or alternate. The representatives will be chosen by the Office directors.
- Executive Secretary (RIMS)
Procedures
- CRs will be made according to the Center SOPP, Center-wide Guidance on Change Requests/Problem Reports for Regulatory Review Automated Support Systems
- Full Board meetings will be regularly scheduled once a month. If necessary, particularly during system development, meetings may be scheduled more frequently
- The Board may conduct virtual "meetings" via e-mail when most efficient
- Minutes of all meetings will be prepared
- Each Office will have one vote on issues brought before the Board
- In making decisions, Board members will be responsible for assuring that they have necessary input from users within their offices
- The Board decision will be based on consensus. If consensus cannot be reached, the CCB Chair will present the issue to the RMCC for decision.
- Any office may appeal a decision to the Center Associate Director for Review Management
- RIMS will be responsible for administrative support of the CCB. This will include:
- Receiving and organizing all CRs
- Maintaining a status list of all CRs
- Providing the Board members lists of CRs for discussion
- Documenting CRs presented and decisions reached
- Disseminating decisions through the appropriate mechanism for the respective system in a timely manner
This Charter will be revised as needed based on experience gained by the CCB.